HHHFNC (Heated Humidified High-Flow Nasal Cannula) Versus NCPAP for Respiratory Distress Syndrome of Prematurity

NCT ID: NCT02570217

Last Updated: 2015-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 316 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

Brief Summary

Preterm infants ranging from 29+0 to 36+6 weeks+days are randomly assigned to one of the following treatments as non invasive respiratory support if they develop mild to moderate Respiratory Distress Syndrome within 72 hrs from birth: 1) NCPAP set at 4-6 cmH2O or 2) HHHFNC providing a flow 4-6 l/min.

The aim of the study is to assess efficacy and safety of relative "new" form of respiratory support (HHHFNC) versus a more common one (NCPAP).

Detailed Description

Preterm infants are eligible to the study if they present mild to moderate Respiratory Distress Syndrome (RDS) defined by the following criteria: need of FiO2 ( Fraction of Inspired Oxygen) ≥0.30 to keep a target SpO2 (Periferal Oxygen Saturation) beetween 88-93% and/or Silverman score ≥5. To confirm the diagnosis a Chest XR is performed as routinarily in the ward before starting the respiratory support.

They are randomly assigned to one of the treatment groups cited in "brief summary" by means of closed envelops. A block randomization is applided with a blok size of 4. The randomization is stratified per groups accoring to gestational age: from 29+0 to 32+6; from 33+0 to 34+6; from 35+0 to 36+6 weeks+days.

Once the treatment is started, for the group NCPAP there is the possibility to switch to the mode "Bi-PAP" if: there are more than 4 episodes of apnoea per hour or more than 2 episodes requiring positive pressure ventilation or if deemed by clinicians for increased work of breathing assesed by the Silverman score.

For all the groups, if the FiO2 requirement is persistently higher than 0.35-0.40 per target SpO2 86-93% and/or dyspnoea defined by Silverman score > 6 after starting the respiratory support, newborns receive Surfactant by "INSURE" technique, involving endotracheal intubation by direct laryngoscopic vision, endotracheal administration of surfactant (Curosurf, Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg and finally extubation.

After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2 86-93% or severe apnea episodes are present (apnea episodes > 4/hr or >2/hr requiring positive pressure ventilation) or at the blood gas (capillary or venous) PaCO2>70 mmHg and pH<7.20, newborns are intubated and mechanically ventilated.

For all the newborns enrolled in the study, capillary or venous blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.

Weaning is started decreasing HHHFNC flow by 1 lpm or nCPAP pressure by 1 cmH2O pressure if infants are presenting FIO2 < 0.30 to target SpO2 and minimal or no signs of respiratory effort. The respiratory support is discontinued for flow ≤ 2 lpm or pressure ≤ 2 cmH2O.

Conditions

Newborn Respiratory Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HHHFNC

The patients receive respiratory support by mean of Heated Humidified High Flow Nasal cannula

Group Type: EXPERIMENTAL

HHHFNC

Intervention Type: DEVICE

infants receive non-invasive respiratory support by mean of HHHFNC

NCPAP

Patients receive respiratory support by Nasal Continuous Positive Airways Pressure(NCPAP)

Group Type: ACTIVE_COMPARATOR

NCPAP

Intervention Type: DEVICE

infants receive non-invasive respiratory support by mean of NCPAP

Interventions

HHHFNC

infants receive non-invasive respiratory support by mean of HHHFNC

Intervention Type: DEVICE

NCPAP

infants receive non-invasive respiratory support by mean of NCPAP

Intervention Type: DEVICE

Other Intervention Names

PRECISION FLOW (Vapotherm,Stevensville, USA); Infant Flow Driver System (EME Ltd, Brighton, Sussex, UK); SiPAP (Viasys Healthcare, Palm Springs, CA)

Eligibility Criteria

Inclusion Criteria

• Inborn
• Parental Consent

Exclusion Criteria

• No parental consent
• Major congenital malformations
• Severe intra ventricular hemorrage diagnosed early after birth

• Minimum Eligible Age: 29 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Anna Lavizzari

UNKNOWN

Sponsor Role: collaborator

Dr Francesca Gaia Ciuffini

UNKNOWN

Sponsor Role: collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role: lead

Responsible Party

Mariarosa Colnaghi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariarosa Colnaghi, MD

Role: STUDY_DIRECTOR

IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

Locations

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy

Milan, , Italy

Countries

Italy

References

Lavizzari A, Colnaghi M, Ciuffini F, Veneroni C, Musumeci S, Cortinovis I, Mosca F. Heated, Humidified High-Flow Nasal Cannula vs Nasal Continuous Positive Airway Pressure for Respiratory Distress Syndrome of Prematurity: A Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2016 Aug 8. doi: 10.1001/jamapediatrics.2016.1243. Online ahead of print.

Reference Type: DERIVED

PMID: 27532363 (View on PubMed)

Other Identifiers

IRCCSMaggioreH

Identifier Type: OTHER

Identifier Source: secondary_id

HHHFNC vs NCPAP 2012

Identifier Type: -

Identifier Source: org_study_id